Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00382824
Recruitment Status : Completed
First Posted : October 2, 2006
Last Update Posted : August 6, 2015
Information provided by (Responsible Party):
Lahey Clinic

Brief Summary:
The clinical syndrome of PSP responds poorly to all available forms of therapy used in Parkinson's Disease (PD). Currently, no effective treatment exists. Coenzyme Q10 in high doses has been shown to be a beneficial therapy in PD and might possibly be a beneficial therapy for PSP. This study will compare the efficacy, safety and tolerability of Coenzyme Q10 versus placebo in patients with atypical parkinsonian syndrome, progressive supranuclear palsy (PSP).

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Atypical Parkinsonism Drug: CoenzymeQ10 Phase 2 Phase 3

Detailed Description:
The study is designed as a multicenter randomized, placebo-controlled, double blind trial. Up to 60 patients with PSP will be enrolled at several centers in the United States

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP): A Multicenter, Randomized, Placebo-controlled, Double Blind Study
Study Start Date : September 2006
Actual Primary Completion Date : September 2013
Actual Study Completion Date : January 2015

Intervention Details:
  • Drug: CoenzymeQ10
    active drug
    Other Name: CoQ10

Primary Outcome Measures :
  1. Rate of Functional decline [ Time Frame: 12 months ]
  2. Functional ability [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 12 months ]
  2. Quality of Life [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients fulfilling the diagnostic criteria of PSP/diagnosed within the past 5 years
  • Either vertical supranuclear palsy or both slowing of vertical saccades
  • Prominent postural instability with falls in the first year of disease onset
  • No evidence of other diseases that could explain the foregoing features

Exclusion Criteria:

  • Current or previous therapeutic use of CoQ10
  • Parkinsonism due to drugs
  • History of pallidotomy, thalamotomy, active deep brain stimulator or fetal tissue transplant
  • History of active epilepsy, stroke, structural brain disease
  • Use of methylphenidate hydrochloride, cinnarizine, reserpine, amphetamines, or monoamine oxidase-A inhibitors within 3 months before the baseline visit.
  • Active cancer or cancer undergoing treatment
  • Participation in other drug studies or the use of other investigational drugs within 30 days before screening.
  • Known hypersensitivity to Coenzyme Q10.
  • Pregnant, planning a pregnancy or nursing woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00382824

United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Principal Investigator: Diana Apetauerova, MD Lahey Clinic

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lahey Clinic Identifier: NCT00382824     History of Changes
Other Study ID Numbers: LaheyC
First Posted: October 2, 2006    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015

Keywords provided by Lahey Clinic:
Progressive Supranuclear Palsy
Atypical Parkinsonism

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Ocular Motility Disorders
Cranial Nerve Diseases
Neurodegenerative Diseases
Eye Diseases
Coenzyme Q10
Growth Substances
Physiological Effects of Drugs